HospitalInspections.org

Based on a review of documentation and an interview with staff, the facility failed to ensure that a properly executed informed consent form for surgery was in the patient's medical record.

Findings were:

During a review of the clinical record for patient #1, nursing notes indicated that a central venous catheter was placed in the internal jugular vein of the patient's left neck at 7:42 am. A consent was obtained prior to the procedure at 6:28 am. It was signed by the patient's daughter but contained no witness signature in the blank labeled "witness".

Facility policy 14076 titled "Permit Disclosure and Consent - Medical and Surgical Procedures" states in part:
"I. General Information:
A. The Disclosure and Consent Form for medical and surgical procedures is completed prior to the patient undergoing any invasive procedure. The appropriate specialty consent will be used, inclusive of the applicable disclosure(s) and authorization(s).
...
IV. Witnessing Informed Consents
A. When the Disclosure and Consent process occurs in the hospital, the patient/guardian signature should be witnessed by a staff member.
B. The staff member is considered a witness to the fact that the informed consent was signed by the patient/guardian.
C. If the patient does not speak/read English, the consent should be secured in the language the patient understands, or the consent may be translated, with the clinical translator signing as a witness or documentation of a translator service."

In an interview with staff #10 on 5-15-18, staff #10 confirmed that the surgical consent should have been signed by a witness to indicate the patient/guardian had given written consent to the procedure.

The above was confirmed in an interview with the Regulatory Compliance Manager, Director of Patient Safety, Senior VP of Patient Services, Director of Critical Care and Clinical Informatics Manager on the afternoon of 5-15-18.